Mitigation Services

Lonza offers risk mitigation for both early and later stage development programs. Early stage mitigation strategies include in silico screening and re-engineering while later stage programs address issues through process development optimization.

Following a complete Developability Assessment, customers will be provided with a full report outlining potential issues highlighting those that pose a high risk. The report will include mitigation options for the candidate. Our bioinformaticians have an extensive range of protein engineering capabilities that have the potential to improve the structure, biological activity and the manufacturing properties of your drug candidate. In addition, we can manufacture non-GMP and cGMP product for in vitro validation of findings, including immunogenicity.

The figure below shows how a developability mitigation workflow could be structured. Early risk assessments can be utilized before committing to host development. Candidates classified as ‘low risk’ can then move directly into process development stages, whereas those candidates identifed as having ‘high risk’ issues can be subject to a number of risk-mitigation strategies depending on where they are in development pipeline.

In cases where programs are still in early stages of development, the selection of an alternative candidate – for example, from display or affinity maturation libraries – can be progressed. Alternatively, molecules can be subjected to a re-engineering program using single, random amino acid substituion to produce new and improved variants. For later-stage programs, where there is only a single candidate option, developability assessment can provide information for a proactive apporach to process development in order to address the predicted issues.